Information was received via email from healthcare provider regarding discrepancies seen with therapy impedance and group usage when patient was in clinic.Tech services (tss) reviewed i would look into this and follow-up with the caller.Patient came in with severe off symptoms that were related to patient inadvertently turning off their dbs at some point in the last few weeks.Once implantable neurostimulator (ins) was turned back on, hcp ran tx impedance and received results for both sides.It only saved the readings for the left ins on the final print out.Regarding group usage, hcp stated patient should have data going back until may.Patient's daughter checked their system right before christmas and it was on so its just been off the last few weeks.There was no group usage available when hcp checked.Hcp turned patient gps back on with a separate connection as they had disconnected to show the daughter what the patient programmer looks like before they turned patient back on.Hcp thought they would've had the group usage data on first reading.No symptoms reported.(b)(6) 2023 (b)(4) (rep): no new information.
|
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|